NIH Director's New Innovator Award (DP2 Clinical Trial Not Allowed) is sponsored by NIH (National Institutes of Health). Supports highly innovative research including new computational approaches to biological and biomedical problems.

Expired PAR-23-198: NIAID New Innovators Awards (DP2 Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title NIAID New Innovators Awards (DP2 Clinical Trial Not Allowed) DP2 NIH Director’s New Innovator Awards March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023 - See Notice NOT-OD-22-198 .

August 8, 2022 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023 - See Notice NOT-OD-22-195. August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy - see Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The NIAID New Innovator Award supports postdoctoral and other candidates in non-independent positions or newly independent Early Stage Investigator s of exceptional creativity who propose novel, original and insightful research concepts with the potential to produce a major impact, test scientific paradigms, or advance key concepts on broad, important problems in biomedical research of priority to NIAID.

Applications proposing unexpected convergence of disciplines, new scientific directions, or the use of novel methodologies are encouraged. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to receipt date Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description In 2007 the NIH Director’s New Innovator Award was launched as part of the Common Fund’s High-Risk, High-Reward Research program , which was created to accelerate the pace of biomedical discoveries by supporting exceptionally creative scientists with highly innovative research. The NIAID New Innovator Awards (DP2) program was developed in 2019 to fulfill additional goals within the institute.

Unlike the Common Fund DP2 program, the NIAID DP2 program does not require faculty appointment at the time of application. The purpose of the NIAID DP2 program is two-fold: research focused, and person focused. The NIAID DP2 program will provide support for creative, novel, high-impact research concepts that may be risky or at a stage too early to fare well in the traditional peer review process.

The NIAID DP2 program seeks to support creative, original and insightful research concepts with the potential to produce a major impact, test scientific paradigms, or advance key concepts on broad, important problems in biomedical research of priority to NIAID . Applications proposing unexpected convergence of disciplines, new scientific directions, or use of novel methodologies are encouraged.

The application review process will emphasize the individual’s distinct contributions to research, potential to move in new scientific directions particularly as they differ from current postdoctoral training and/or involve novel methodologies and approaches, and the creativity and originality of the proposed research.

Proposed approaches should be insightful and based on strong premise; although preliminary data is not required, demonstration of the potential of the applicant and strong rationale indicating the likelihood of success of the proposed concepts are highly recommended.

The NIAID DP2 program is only available to postdoctoral, non-independent, or newly independent investigators who also have Early Stage Investigator status (defined as a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award) with the following additional requirements: applicants must have a research or clinical doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD, or equivalent doctoral degree), or a combined research and clinical doctoral degree.

both U.S. and non-U.S. citizens may apply. $300K in direct costs per year for up to five years may be requested. applicants must have Early Stage Investigator status.

For newly independent applicants: the applicant must be within the first year of a faculty position or equivalent at a U.S. based institution at the time of application submission. For postdoctoral and other non-independent applicants: if selected for award, applicants must transition to an independent faculty position or equivalent at a U.S.-based institution within one year in order to activate the award.

For more information on eligibility see additional information under Eligible Individuals (Program Directors/Principal Investigators). The NIAID mission is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. Applications in any topic within the broad mission of NIAID are welcome.

Please note that the DP2 activity code does not allow Human Fetal Tissue research (see NOT-OD-19-128 ). Two program meetings will be held over the project period to foster collaborations, report progress, seek new research directions and ideas, and update NIAID. These meetings will be attended by the PD(s)/PI(s) and NIAID staff.

The location of the meetings will be in the Bethesda Maryland area. For more details regarding this DP2 NOFO, please see FAQs on the NIAID website ( https://www. niaid.

nih. gov/grants-contracts/questions-answers-par-ai-dp2 ). See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are limited to $300K direct costs per year including travel costs for program meetings and need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

Applicants for DP2 awards are encouraged to follow the ORCID link from their Personal Profiles in the eRA Commons, where they can either link their eRA profiles to existing ORCID accounts or create ORCID profiles and link them back to the eRA Commons. For more information see https://grants. nih.

gov/grants/guide/notice-files/NOT-OD-19-109. html. Multiple PD(s)/PI(s) are NOT allowed.

The PD/PI of the application must be a postdoctoral, non-independent, or newly independent investigator (defined as within the first year of a faculty position or equivalent at a U.S. based institution at the time of application submission) who also has Early Stage Investigator status. See the list of NIH grants that a PD/PI can hold and still be considered an ESI .

Also note that NIH will consider requests to extend the ESI status period for researches with lapses in their research or research training. Please see Early Stage Investigator Extensions for more information. Individuals are eligible if they have been, or currently are, the PD/PI of an NIH R03 or R21 grant or an equivalent non-NIH award.

Applicants may submit or have an NIH R01 or equivalent grant application pending concurrently with their NIAID New Innovator Award application if it does not overlap substantially with their NIAID New Innovator Award application. However, if that pending grant becomes active prior to the NIAID New Innovator Award, the applicant is no longer eligible to receive the NIAID New Innovator Award.

Applicants may submit or have NIH Research Career Development Awards pending concurrently with their NIAID New Innovator Award application as long as the projects are not highly overlapping. However, NIAID New Innovator Recipients are not eligible for concurrent or subsequent Research Career Development Awards of any type such as mentored K or R00 career development awards.

If the applicant is awarded a Research Career Development Award, the NIAID New Innovator Award cannot be awarded until the applicant relinquishes the Research Career Development Award. Applicants must have a research or clinical doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD, or equivalent doctoral degree), or a combined research and clinical doctoral degree. Both U.S. and non-U.S. citizens are eligible to apply.

At the time of award, the individual must be a U.S. citizen or a non-citizen national of the U.S. or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status), or be a non-U.S. citizen.

For applications submitted on behalf of non-U.S. citizens with temporary U.S. visas, visa status must allow the PD/PI to conduct and complete the proposed research at a U.S. based institution. The applicant institution at the time of award activation is responsible for determining and documenting, that the candidate's visa will allow him or her to remain in the U.S. long enough to complete the award.

Recipients are required to commit at least three person-months (25%) of their research effort each year to activities supported by the NIAID DP2 award. Applicants must hold an independent research position at a U.S. based institution by the time of award activation.

For this NOFO, an “independent research position” is a position that automatically confers eligibility to the investigator (based on institutional policy) to apply for R01 grants with appropriate institutional commitment of facilities for the conduct of the proposed research.

The following is provided as an aid to determine whether an applicant should submit as an independent vs non-independent investigator: Evidence for non-independence may include: The candidate’s research is entirely funded by another investigator’s grants. The candidate’s research is conducted entirely in another investigator’s assigned space.

According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students. According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research grant application (e.g., R01). The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.

In addition, the following information is applicable for postdoctoral applicants: The applicant institution is the institution where the postdoctoral applicant is appointed at the time of application submission. Individuals in non-independent positions at an institution that appoints postdoctoral fellows with other titles are encouraged to obtain confirmation of their eligibility before preparing an application.

It is incumbent upon the candidate to ensure that the position s/he is in complies with the eligibility requirement prior to submitting an application. Postdoctoral awardees must have transitioned to a faculty position or equivalent at a U.S. based institution prior to award activation.

For NIH Intramural Program postdoctoral applicants, the NIAID DP2 award can only be activated after the applicant has transitioned to a faculty position or equivalent at a U.S. extramural institution.

In addition, the following requirements are also applicable for newly independent applicants: The applicant must be within the first year of a faculty position or equivalent at a U.S. based institution at the time of application submission. It is incumbent upon the candidate to ensure that the position s/he is in complies with the eligibility requirement prior to submitting an application.

For more details regarding eligibility requirements, see FAQs on the NIAID website ( https://www. niaid. nih.

gov/grants-contracts/questions-answers-par-ai-dp2 ). Individuals not affiliated with an organization may apply ( specific information is available for unaffiliated candidates ). This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ) Section IV. Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.

gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this NOFO.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Type of Application: Must be "New".

Complete the “Estimated Project Funding” section as follows: Total Federal Funds Requested: Enter $1,500,000. Total Non-Federal Funds: Enter $0. Total Federal & Non-Federal Funds: Enter $1,500,000.

Estimated Program Income: Enter $0. Note: Only the five-year total ($1. 5 million) should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds."

A detailed budget and budget forms are not required and will not be accepted. If the application is selected for funding, detailed budgets including travel costs for the PD/PI to attend the Program Meetings in the Bethesda MD area and applicable F&A will be requested with the 'Just in Time' request. If applicable, detailed subaward budget forms and budget justification will also be requested with the ‘Just in Time’ request.

SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Bibliography & References Cited: DO NOT USE this attachment. Provide reference and bibliography as part of an attachment in the Other Attachments section (see below).

Other Attachments: Attach the following document(s) in this section: Bibliography & References Cited with a filename of “Bibliography_References_Cited.

pdf” SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Profile – Project Director/Principal Investigator Field – Biographical sketch: All applicants must complete the education/training section of the Biographical sketch.

Entries should accurately reflect either postdoctoral or newly independent status and Early Stage Investigator status. Current and Pending Support: Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project. Profile – Senior Key Person 1: DO NOT USE.

Only the PD/PI may serve as senior/key personnel. Research and Related Senior/Key Person Profile (Expanded) - Additional Senior/Key Person Profiles(s): DO NOT USE. Only the PD/PI may serve as senior/key personnel.

Research and Related Senior/Key Person Profile (Expanded) - Additional Biographical Sketch(es): DO NOT USE. Only the PD/PI may submit a Biographical Sketch. Research and Related Senior/Key Person Profile (Expanded) - Additional Current and Pending Support (s): DO NOT USE.

Only the PD/PI may submit Current and Pending Support. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed research plan.

Briefly highlight as applicable the new scientific direction of the proposed work, including how the goals are distinct from postdoctoral training and/or involve novel methodologies and approaches.

Research Strategy: The research strategy should broadly include the following: (1) the significance and potential impact of the research, (2) what makes the approach(es) exceptionally creative, (3) a discussion of how the research promotes expansion beyond the applicant’s current research and promotes independence, (4) how risks and challenges will be addressed, and (5) the applicant’s qualifications for this award addressing potential for growth.

The description of the scientific plan should be written at a level appropriate for reviewers who are broadly knowledgeable but may not be directly involved in the proposed area of research. A detailed experimental plan is not required. Applicants should address unusual or prolonged training periods e.g., more than seven years as a graduate student or more than five years as a postdoctoral fellow.

In addition, the research plan should specifically address the following using clearly marked sections: Project Description and Approach: Clearly describe the scientific challenge or opportunity to be addressed, its importance, and how addressing this would have a major impact on a broad area of science relevant to the NIAID mission.

Provide a coherent strategy which includes the rationale for and/or hypothesis to be tested and clearly describes the overall approach. Include a discussion of how results will be analyzed, interpreted, and used to further future experiments.

State clearly and concisely what makes the project creative, original, or novel and discuss how the approach is designed to be insightful and innovative in the context of the current state-of-the-art of the field. Discuss if applicable how the proposed approach promotes an unexpected convergence of scientific disciplines. Discuss alternate plans in the event these approaches are not successful.

Note: Detailed experimental plans and methods should not be provided. However, the applicant must still convey a clear sense of what is being proposed and why. State in the application: To comply with this NOFO, detailed experimental plans and methods are not included.

Note: Preliminary or unpublished results are not required; however, a discussion and strong rationale supporting the likelihood of success of the proposed concepts are required. Preliminary or unpublished results may be included in summary form at the discretion of the applicant.

Investigator qualifications: Provide information on training and experience to date by discussing specific contributions to the field and contributions to publications and presentations noting areas of originality or creative input. Discuss the potential for growth beyond postdoctoral work, expansion beyond the current environment and plans to move towards greater independence.

Provide evidence to support claims of innovativeness and creativity in the proposed research concepts. For example, discuss what personal qualities and experiences demonstrate inclinations to question paradigms and work with intellectual uncertainties, develop unique collaborations, integrate varied sources of information, or develop novel approaches when new challenges or opportunities arise.

Suitability for the New Innovator Award program: Indicate why the planned research is uniquely suited to the New Innovator Award rather than a more “traditional” grant mechanism. Statement of research effort commitment: Include a statement indicating that, if chosen to receive an award, the applicant will commit a minimum of three person-months (25%) of his/her research effort to the project supported by the New Innovator Award.

Description of Institutional Environment: For postdoctoral or non-independent applicants who have not accepted a faculty position or equivalent at a U.S. based institution only (up to 1 page): Due to the nature of this award, the postdoctoral or non-independent applicant may not have identified a sponsoring institution at the time of application submission.

Those applicants should describe the types of facilities, resources, and the institutional research environment needed to conduct the proposed research and aid the development of the applicant’s research career and transition to an independent investigator.

For newly independent applicants only (up to 1 page): describe how the facilities, resources, and the institutional research environment available to the applicant will aid the development of the applicant’s research concepts and continued growth as an independent investigator.

For a postdoctoral or non-independent investigator, a statement from the current mentor/supervisor indicating that the applicant is free to continue the proposed scientific approach outside of the postdoctoral laboratory setting should be included as a Letter of Support. If applicable, letters of collaboration from any collaborator indicating their support and role in the proposed project may be included as Letters of Support.

All applicants should include individual letter(s) from at least one(1) and up to three (3) current or prior mentors/supervisors of the candidate indicating contributions made by the applicant to previously published work and a description in the mentors'/supervisors' words of the applicant's qualities that would indicate the applicant is a strong NIAID DP2 program candidate (e.g., imagination, depth of knowledge).

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R& R ) Application Guide. Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5.